Electrochemical diagnostic devices are analytical tools combining a chemical or biochemical recognition component (e.g., an enzyme or antibody) with a physical transducer such as a platinum electrode. The chemical or biochemical recognition component can be used to selectively interact with an analyte of interest and generate an electrical signal through the transducer. The selectivity of certain biochemical recognition components makes it possible to develop electrochemical sensors which can accurately detect certain biological analytes in blood.
In vitro diagnostic testing has traditionally been performed at large, well-equipped testing centers. These conventional testing centers offer efficient and accurate testing of a high volume of fluid samples, but are not able to offer immediate results. A medical practitioner must collect fluid samples, the samples must be transported to a laboratory, then processed by the laboratory, and finally the results are communicated to the patient. Conventional in vitro diagnostic testing does not offer immediate results.
Also, conventional in vitro diagnostic testing requires trained laboratory technicians to perform the testing in order to ensure the accuracy and reliability of the test. User errors by the person handling the sample can result in contamination of surfaces, spilled specimens, or damage to the diagnostic device resulting in extensive repair and maintenance costs. Conventional in vitro diagnostic testing requires a skilled technician to perform multiple stages of the testing process, and is still subject to user error.